BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKSMAN

    MDR report key: 6097872 · Received November 11, 2016

    Report

    Report Number
    2029214-2016-01007
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 29, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. ONCE COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION HAS ALSO BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    THE MARKSMAN CATHETER WAS RETURNED FOR EVALUATION. THIS DEVICE WAS USED TO TREAT AN ISCHEMIC STROKE. THE SOLITAIRE WAS NOT RETURNED FOR EVALUATION; IN ADDITION, THE PATIENT ANATOMY CONDITION WAS NOT REPORTED; THEREFORE ANY CONTRIBUTING FACTORS FROM THE SOLITAIRE AND THE PATIENT ANATOMY COULD NOT BE ASSESSED. BASED ON THE ANALYSIS FINDINGS AND THE REPORTED EVENT DETAILS, THE CUSTOMER¿S REPORT OF ¿CATHETER SEPARATION/BREAK¿ ISSUE WAS CONFIRMED AS THE RETURNED MARKSMAN CATHETER WAS OBSERVED TO BE SEPARATED INTO 2 SECTIONS. THE BROKEN ENDS OF THE CATHETER EXHIBITED WITH STRETCHING AND NECKING WHICH INDICATED THAT THE CATHETER SEPARATED WHEN EXCEEDING THE TENSILE STRENGTH OF THE TUBING MATERIAL. ADDITIONALLY, THE DAMAGES SEEN ON THE CATHETER BODY (STRETCHING /ACCORDIONING / KINKING) INDICATE THERE WAS EXCESSIVE FORCE USED (PUSHING AND PULLING) AGAINST RESISTANCE. NO EVIDENCE WAS FOUND TO SUGGEST THAT THE DEVICE FAILED TO MEET SPECIFICATIONS AND THE LOT HISTORY RECORD HAS BEEN REVIEWED AND NO QUALITY ISSUES HAVE BEEN NOTED. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGE AND IRREGULARITIES DURING MANUFACTURE. PER THE INSTRUCTIONS FOR USE (IFU): ¿IF EXCESSIVE RESISTANCE IS ENCOUNTERED DURING RECOVERY OF THE SOLITAIRE¿ FR REVASCULARIZATION D EVICE, DISCONTINUE THE RECOVERY AND IDENTIFY THE CAUSE OF THE RESISTANCE. DO NOT RECOVER (I.E. PULL BACK) THE DEVICE WHEN ENCOUNTERING EXCESSIVE RESISTANCE. INSTEAD, RESHEATH THE DEVICE WITH THE MICRO CATHETER AND THEN, REMOVE THE ENTIRE SYSTEM UNDER ASPIRATION. IF RESISTANCE IS ENCOUNTERED DURING RESHEATHING, DISCONTINUE AND REMOVE THE ENTIRE SYSTEM UNDER ASPIRATION. NEVER ADVANCE OR WITHDRAW AN INTRALUMENAL DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF RESISTANCE IS DETERMINED BY FLUOROSCOPY. IF THE CAUSE CANNOT BE DETERMINED, WITHDRAW THE CATHETER. MOVEMENT OF THE MICRO CATHETER AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE MICRO CATHETER, OR THE VESSEL.¿

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT WAS RECEIVING TREATMENT IN THE M2. THERE WAS NO VESSEL TORTUOSITY, STENOSIS, OR VASOSPASM DURING THE PROCEDURE. THE CATHETER WAS FLUSHED AS DIRECTED AND THE SOLITAIRE WAS USED SUCCESSFULLY, FLOW WAS RESTORED IN THE M2.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE TIP OF THE MARKSMAN CATHETER CAME OFF WHEN THEY WERE REMOVING A MECHANICAL THROMBECTOMY DEVICE DURING A STROKE PROCEDURE. THE DEVICES USED IN THE PROCEDURE WERE ALL PREPARED PER IFU. THE CATHETER WAS FLUSHED AS DIRECTED AND THE MECHANICAL THROMBECTOMY DEVICE WAS USED SUCCESSFULLY; FLOW WAS RESTORED. NOTHING WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746936 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) FA-55150-1030 A296924

    Patients

    Seq Age Sex Outcome Treatment
    1